Pharmacy Times, Volume 0, 0

The newly formed International Serious Adverse EventsConsortium (SAEC) plans to launch 2 initial research programsdesigned to identify genetic markers that may help predictwhich individuals are at risk for serious drug-related adverseevents.

The studies will address drug-related liver toxicity and therare but serious drug-related skin condition Stevens-Johnsonsyndrome. Patients respond differently to medicines, and allmedicines can have side effects in some individuals.

The SAEC's work is based on the hypothesis that these differenceshave a genetic basis, and its research studies willexamine the impact genes can have on how individualsrespond to drugs. The findings will be made available to theresearch community for further study. The groups' objectivesare as follows:

  • Reduce the significant patient and economic costs associatedwith drug-related SAEs
  • Improve the flow of safe and effective medical advances byaddressing safety issues regarding new drugs before theyenter the marketplace
  • Establish common pharmacogenetic research platforms forSAEC members and other academic institutions to determinerelationships between genetic variations and SAEs
  • Encourage further study by creating a public databaseSAEC is a nonprofit partnership comprised of leading pharmaceuticalcompanies, academic institutions, and the FDA.